Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL Manufacturer: Amneal Pharmaceuticals, LLC
Recall Date: 11/08/2019
Reason: Due to potential N-Nitrosodimethylamine (NDMA) amounts being above levels established by the FDA. FDA Notice
Ranitidine Tablets 150mg, Ranitidine Capsules 150 mg, Ranitidine Capsules 300 mg and Ranitidine Syrup 15 mg/mLRanitidine Tablets, Capsules, and Syrup Manufacturer: Aurobindo Pharma USA, Inc.
Recall Date: 11/06/2019
Reason: Due to the detection of Nitrosodimethylamine (NDMA) impurity. FDA Notice
Ranitidine Syrup (Oral Solution, USP), 15 mg/mL Manufacturer: Lannett Company, Inc.
Recall Date: 10/25/2019
Reason: Due to levels of N-Nitrosodimethylamine (NDMA) being above the levels recently established by the FDA. FDA Notice
Ranitidine Tablets & Capsules Manufacturer: Dr. Reddy’s Laboratories Ltd.
Recall Date: 10/23/2019
Reason: Contamination with N-Nitrosodimethylamine (NDMA) above the levels established by the FDA. FDA Notice
Losartan Potassium 50mg and Losartan Potassium/Hydrochlorothiazide combination Tablets 50mg/12.5mg, 100mg/12.5mg and 100mg/25mg Recall Date: 06/26/2019 Manufacturer: Macleods Pharmaceuticals, Ltd.
Reason: Detection of trace amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable daily intake levels released by the FDA. FDA Notice
Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg Recall Date: 02/22/2019 Manufacturer: Macleods Pharmaceuticals, Ltd.
Reason: Detection of trace amounts of an unexpected impurity (NDEA) above the interim acceptable daily intake levels released by the FDA. FDA Notice
Losartan Potassium Tablets, USP and Losartan Potassium and Hydrochlorothiazide Tablets, USP Recall Date: 01/22/19 Manufacturer: Torrent Pharmaceuticals Limited
Reason: Detection of trace amounts of an N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA. FDA Notice
Irbesartan and Irbesartan HCTZ Tablets Recall Date: 01/18/2019 Manufacturer: Prinston Pharmaceutical Inc. dba Solco Healthcare LLC
Reason: Detection of trace amount of N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA. FDA Notice
Valsartan and Valsartan-HCTZ Tablets, USP Recall Date: 07/18/2018 Manufacturers: Prinston Pharmaceuticals, and TEVA Pharmaceuticals.
Reason: It has been found that the recalled products for impurity detected. This may cause unexpected health risks. FDA Notice – Prinston Pharmaceuticals FDA Notice – TEVA Pharmaceuticals
Lunesta (eszopiclone), Sonata (zaleplon), Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist (zolpidem) Notification Date: 04/30/2019 Certain Prescription Insomnia Medicines: New Boxed Warning – Due to Risk of Serious Injuries Caused by Sleepwalking, Sleep Driving and Engaging in Other Activities While Not Fully Awake FDA Notice